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Otago Law Review |
Last Updated: 23 April 2015
“Incidental Findings” During Surgery: A Surgical
Dilemma or the Price Paid for Autonomy?
Jeanne Snelling* Lynley Anderson** Andre van Rij*** Introduction
As medicine and technology advances, it is becoming increasingly common to identify unexpected or “incidental” anomalies in the course of performing one of the vast array of medical interventions that encompass clinical research, diagnostic procedures, or invasive treatment. A broad range of findings may be described as “incidental”. These include, but are not limited to, those dubbed “incidentalomas”. Incidentalomas are tumour(s) discovered by coincidence during an imaging or scanning procedure, such as a CT scan. Another category of “incidental finding” that is currently attracting significant international debate are those additional findings discovered in the context of genetic testing, such as a genetic predisposition to late onset disease. A different category of incidental finding – perhaps with the longest pedigree – concerns unanticipated anomalies that are discovered in the course of surgery after the patient has been anaesthetised. Discussions as to how to manage “incidental findings” falling within the first two of these categories have become ubiquitous in the medical, ethical and legal literature.1 However, this paper is concerned only with the latter category of incidental finding
– an abnormality discovered in the course of surgery that is unrelated to the primary procedure being performed.
For the purpose of this analysis, an incidental finding is an unexpected finding that is not related to the surgery for which a patient has consented. To be clear, if an abnormality was foreseeable by a reasonably competent surgeon in advance (ie as a possible differential diagnosis or simply more extensive disease than first thought) and the patient could have been informed preoperatively of its potential occurrence, it is not an “incidental” finding. Rather, incidental findings in this context are those that arise unexpectedly and in addition to the condition/indication for which a procedure is being performed.
Currently, there is a lack of consensus regarding the appropriate
* Research Fellow, Bioethics and Health Law, Bioethics Centre, University of Otago.
** Senior Lecturer, Bioethics Centre, University of Otago.
*** Professor of Surgery, Dunedin School of Medicine, University of Otago.
The authors would like to acknowledge the immensely helpful comments
made by Professors PDG Skegg and Nicola Peart in the course of writing
this paper.
1 B Roehr “Test Providers Should Anticipate Incidental and Secondary
Findings, Says US Bioethics Commission” (2013) 347 BMJ f7525;
M Pampaloni and A Win “Prevalence and Characteristics of Incidentalomas
Discovered by Whole Body FDG PET CT” (2012) International Journal of
Molecular Imaging 476763.
response to such findings discovered during surgery. If the incidental finding constitutes a medical emergency, medical intervention is justified under the common law doctrine of necessity.2 But such emergencies aside, considerable complexity arises in the context of unexpected anomalies that warrant intervention, but which were not the subject of specific preoperative discussion or consent.
On one account, a surgeon should not act in regard to an incidental finding unless there is an imminent risk to the patient’s life or health because the patient has not provided express consent. However, some surgeons and patients alike may be frustrated by such a strict application of the law, or at least to the law so construed.
By way of example, it is possible that a patient who is told post- operatively that her thickened and abnormal looking appendix observed in the course of surgery for gallstones will likely require surgery in the future, will be extremely frustrated given the inconvenience associated with additional surgery, hospitalisation, and recovery time. Consequently, a surgeon who removes the appendix might be reasonably safe in presuming that most patients would, retrospectively, approve such surgery. This obviously presupposes a situation where the surgeon acts in the best interest of the patient and with reasonable care and skill. However, the impact on the surgeon should a patient subsequently complain and who must then go through a formal complaints process, should not be underestimated.
There are potential gaps between what surgeons might consider appropriate surgical practice, the reasonable expectations of a patient and a strict application of the law of consent in this particular context. This presents a dilemma for surgeons and a dimension of uncertainty for both patients and surgeons alike. While intervening may be considered an infringement of the patient’s autonomy on one hand, refraining may be considered to exact too high a price on the patient who is potentially worse off on the other.
This article examines the implications of incidental findings for the law and
for professional practice, and asks what might constitute
an appropriate legal
response. Section I first outlines the legal requirement for consent in terms of
the criminal and common law.
It considers the few, mostly Canadian, cases that
have directly dealt with these types of incidental findings. Section II
discusses
the New Zealand medical law context and relevant cases that have
arisen for adjudication involving consent in general. The discussion
in
sections I and II seeks to identify principles applicable to the issue of
incidental findings. Section III considers possible
legal approaches. It
concludes by suggesting that, subject to certain safeguards, some flexibility
ought to be imported into
2 Marshall v Curry [1933] 3 DLR 260; Murray v McMurchy (1949) 2 DLR 442;
Re F (Mental Patient: Sterilisation) [1991] UKHL 1; [1990] 2 AC 1; X v Y (alt cit R v R) [2004] 2
NZLR 847 at [56]; R v Harris HC Palmerston North CRI-2006-054-001008,
21 November 2006 at [41].
law and policy and proposes a legal test in an attempt to achieve this
goal.
I The Requirement of Consent
The central issue in this situation is the legal requirement for consent to
medical treatment, which is premised on the principle
of autonomy. This holds
that individuals should be free to make decisions in accordance with their own
values and life plan. In this
context it has become trite to refer to Justice
Cardozo’s articulation of the fundamental principle
that:3
[e]very human being of adult years and sound mind has a right to determine
what shall be done with his own body; and a surgeon who
performs an operation
without his patient’s consent commits an assault [sic] for which he is
liable in damages. This is true
except in cases of emergency where the patient
is unconscious and where it is necessary to operate before consent can be
obtained.
This fundamental maxim eloquently articulated by Cardozo J is one of those most commonly reiterated in medical law texts: surgery performed on a legally competent patient without consent, in a non-emergency situation, is unlawful.4 More specifically, surgery performed in the absence of consent, in such circumstances where it could practicably be obtained, potentially constitutes either a battery or negligence and the surgeon may face legal proceedings as a result.5 This juridical position is reflected in New Zealand’s Crimes Act 1961 as well as the civil framework governing the provision of medical treatment.
A Criminal Law
Section 61 of the Crimes Act 1961 provides that:6
3 Schloendorff v Society of New York Hospital (1914) 211 NYR 125 at 129.
Although Cardozo J referred to “assault” he was clearly referring to the
tort of battery in this context.
4 Despite the conviction with which Cardozo J articulated this fundamental
tenet, it did not ultimately provide the unfortunate Mrs Schloendorff
any relief due to Cardozo J’s creative deployment of a legal technicality.
Cardozo J held that Mrs Schloendorff’s tortious action against the hospital,
a charitable institution, could not succeed because of the doctrine of
charitable immunity. See P Lombardo “Phantom Tumors and Hysterical
Women: Revising Our View of the Schloendorff Case” (2005) 33 Journal
of Law, Medicine and Ethics 791.
5 Battery refers to an unjustified and unwanted application of force to
another person’s body. In Reibl v Hughes [1980] 2 SCR 880 at 890 Laskin
J held that actions in tort for battery should be confined to instances
when “no consent at all” has been provided (emergency situations aside)
or where an intervention is performed “beyond that to which there
was consent”. Claims involving a failure to disclose relevant risks of a
procedure to a patient fall within the scope of negligence.
6 See PDG Skegg “‘Surgical Operation’ Provisions in Commonwealth
Criminal Codes” in H Ahrens and others (eds) Medizin und Haftung
(Springer, Berlin, 2009) 581 at 584. Skegg traces the rationale underlying
section 61 back through the Act’s earlier versions to (Victorian jurist and
criminal law scholar) Sir James Fitzjames Stephen’s Digest of
the Criminal
[e]very one is protected from criminal responsibility for performing
with reasonable care and skill any surgical operation upon any person for his
benefit, if the performance of the operation was reasonable,
having regard to the patient’s state at the time and to all the
circumstances of the case.
While section 61 is concerned with the standard of surgical care, the following provision imposes an explicit statutory requirement of consent to surgical treatment. Section 61A (inserted into the Crimes Act 1961 in
1977) provides that:7
[e]very one is protected from criminal responsibility for performing
with reasonable care and skill any surgical operation upon any person if the
operation is performed
with the consent of that person, or of any person
lawfully entitled to consent on his behalf to the operation, and for a
lawful purpose.
Despite this requirement, there are two reasons why the criminal law is unlikely (although it is not an impossibility) to be invoked in the context of an incidental finding. First, the Crimes Act 1961 retains all common law justifications, excuses, or defences to any charge under the Act, unless they have been amended by or are inconsistent with the Act.8 If such a justification exists in the common law in this context, which is at least arguable, a surgeon would be immune from criminal liability. Second, in the context of an incidental finding where consent has been obtained to the primary surgery, any claim is likely to be subsumed under the civil law rather than the criminal as it is arguably a matter of the scope of consent, rather than the complete absence of it.9 This is particularly so if the surgery itself was capable of being considered “reasonable” in the patient’s circumstances and was performed for their “benefit” (s 61). However, while sections 61 and 61A are likely to provide immunity under the criminal law, that alone does not establish that a surgical intervention is justifiable in terms of the civil law.
New Zealand medical law is unique in several respects, primarily in terms of
its adoption of a statutory compensation scheme which
provides eligible persons
with cover for personal injury arising from treatment provided by a registered
health professional.10 The trade-off for such a scheme, however, is
the removal of the legal capacity to sue a clinician
Law and the resulting Criminal Code (Indictable Offences Bill) 1878. Seemingly surgical operation provisions initially resulted from the view that, by their very nature, surgical interventions caused bodily injury or harm. Consequently the original provisions provided the right to consent to such bodily injury and conferred immunity on the surgeon under criminal law, subject to the proviso that the surgery was performed in good faith for the benefit of the patient. Section 61 replicates that of clause 68 of Criminal Code Bill 1880, which did not contain a reference to consent. However s 61A was subsequently introduced.
7 Crimes Amendment Act 1977.
8 Crimes Act 1961, s 20.
9 Reibl v Hughes above n 5.
10 Accident Compensation Act 2001, s 32.
for any personal injury that attracts cover under the legislative regime.11
Further, the establishment of the Office of the Health and Disability
Commissioner in the mid 1990s, mandated with authority to formulate
a patient Code of Rights and to investigate patient complaints, largely
establishes the applicable civil framework in this context.12 However the
common law, to the extent that it informed the framework developed
and its application in practice, as well as its residual scope, remains of
relevance. Consequently the following examines the sparse, primarily
Canadian, case law that exists in the context of incidental findings, before
returning to a discussion of the New Zealand context.
B Common Law: Non-consensual Surgical Intervention and the Tort
of Battery
In Marshall v Curry13 the plaintiff brought an action in damages for negligence and assault after a surgeon performing a hernia repair also removed the plaintiff’s apparently diseased testicle. The surgeon justified the surgery on the basis that, if he did not, gangrene may develop. The court concluded that after discovering a condition that could not have been anticipated nor reasonably foreseen, the surgeon acted in the interest of the plaintiff for the protection of his health and possibly life. It stated: “... where a great emergency which could not be anticipated arises ... it is the surgeon’s duty to act in order to save the life or preserve the health of the patient”.14
Essentially the same legal test was applied in the later case of Murray v McMurchy,15 although with a different outcome on the facts. In Murray the Supreme Court of British Columbia found the doctor liable for trespass to the person (battery) when, after discovering uterine fibroids during a caesarean section, he performed a tubal ligation (sterilisation). The surgeon defended the procedure on the grounds that a subsequent pregnancy would be hazardous to the patient. Although not explored in the judgment, it is striking that the procedure undertaken by the surgeon did not directly address the primary pathology, the fibroids themselves, which raises questions about the surgeon’s conduct and clinical reasoning.
The Court was unequivocal that a doctor is only justified in proceeding
without consent if it is “necessary as opposed to being
convenient, for
the protection of the life or even the preservation of the health of the
patient”.16 This doctrine was followed in subsequent
litigation concerning an incidental finding heard in the Queen’s Bench of
Saskatoon,
Canada. The case, which was reported in the Canadian Medical Journal,
involved a 28 year old unmarried woman who underwent a non-acute
11 Accident Compensation Act 2001, s 317.
12 Health and Disability Commissioner Act 1994.
13 Marshall v Curry above n 2.
14 At 260.
15 Murray v McMurchy above n 2.
16 At 443–444.
appendectomy during which endometriosis (abnormal growth of uterine tissue
outside the uterus) was discovered.17 The surgeon removed both
ovaries and one fallopian tube, which immediately rendered the patient
infertile. The patient subsequently
brought an action for damages. At the
conclusion of the proceedings, Doiron J stated:18
[i]n my opinion the defendant acted in accordance with his best judgment and
was possessed of the knowledge and skill to perform the
operation, but in the
final analysis it is for the patient to decide whether she consents to the
operation and have the surgeon of
her choice perform it.
Given that the surgery removed the woman’s reproductive capacity and would presumably have induced premature menopause, the deference paid to the surgeon’s clinical judgment seems, at least in contemporary times, generous. Nevertheless, the surgeon was found liable for battery.
What is notable about these cases is that all involved the non- consensual removal of fertility. The surgical intervention had far reaching implications on the lives of each of the patients involved. Arguably it was not just a simple breach of autonomy, but one that involved the removal of a vital human function which, for many, is intricately linked with one’s identity and life course.
Apart from Canada, there is a dearth of Commonwealth cases involving
incidental findings, although the UK House of Lords considered
the matter in
passing in Re F.19 Re F involved a patient whose lack
of capacity was permanent due to intellectual disability. In the course of the
decision, the House of
Lords (then the highest appellate court in the United
Kingdom) endorsed the doctrine of necessity as providing justification for
treating a patient who is temporarily unable to consent in the case of
emergency. This was subject to the limit that no more should
be done than is
“reasonably required, in the best interests of the patient, before he
recovers consciousness”.20 Lord Goff explained this limitation
as derived from “the fact that the plaintiff is expected before long to
regain consciousness
and can then be consulted about longer term
measures”.21 However in the case of permanent incapacity
where a legal proxy was not available, the Court held that a doctor may provide
medical
treatment in the best interests of the patient.22 The
important point for the purpose of this discussion is that Lord Goff, in
particular, expressly noted the complexity associated
with the case of
incidental findings when he stated:23
17 See T Fisher (MD) “Medico-Legal: Trespass” (1956) 74 CMJ 308.
18 At 310.
19 Re F above n 2.
20 At 77.
21 At 77. The doctrine of necessity has since been endorsed in New Zealand.
See R v Harris HC Palmerston North CRI-2006-054-001008, 21 November
2006 at [41].
22 Re F above n 2, at 76-–77 per Lord Goff.
23 At 77. See also Butler Sloss LJ at 37.
The point has, however, arisen in a more acute form where a surgeon, in the
course of an operation, discovers some other condition
which, in his opinion,
requires operative treatment for which he has not received the patient’s
consent. In what circumstances
he should postpone the further treatment until he
has received the patient’s consent, is a difficult matter which has
troubled
the Canadian courts but which it is not necessary for your Lordships to
consider in the present case (citation omitted).
Clearly neither Lord Goff, nor the other Lords, provided definitive judicial guidance on the issue of incidental findings. Obviously, the Canadian cases involved extreme fact scenarios, and the House of Lords deliberately refrained from wading into debate on the matter. Despite this, Re F is often cited (somewhat misleadingly, given the emphasis on necessity, not emergency) as authority for limiting all non- consensual medical interventions on temporarily incompetent patients to emergencies only.
Yet it appears wide open to the courts to articulate the circumstances (if any) in which addressing an incidental finding might be considered lawful in a non-emergency situation. It is suggested that such an approach could be premised on public policy grounds that, in limited circumstances, it is in the public interest to find that a surgeon may provide appropriate surgical intervention in relation to an incidental finding and not be civilly liable. Clearly certain considerations, such as the nature of the incidental finding and the implications for the patient as a result of intervention, may distinguish the propriety of some surgical interventions in this context.
This issue is far from moot given evidence that some surgeons, when confronted with an incidental finding, will act as they consider is clinically appropriate, and this does not always presuppose an emergency situation.24 As already demonstrated there are very few legal cases directly on point. Because of this lack of jurisprudential history, one could assume that, for the most part, such surgical interventions create few problems and patients are grateful to surgeon’s who take the initiative in such circumstances. A less generous assumption is that patients may simply be unaware that such interventions have occurred. Either way, there is clear merit in examining the issue of incidental findings to establish decision-making principles and boundaries for both clinicians and patients.
Given this, the following section examines the approach taken by the courts
in situations involving surgical interventions where a
lack of consent has been
alleged. The cases discussed provide some indication of the principles that
might be used to determine appropriate
clinical and
24 A Hayes-Jordan “Surgical Management of the Incidentally Identified Ovarian Mass” (2005) 14 Semin Pediatr Surg 106 at 108; J Hall and S Stein “Unexpected Intra-operative Findings” (2013) 93 Surg Clin N Am 45 at
47; A Van Rij and others “Survey of Members of the Royal Australasian
College of Surgeons” (Unpublished study, Department
of Surgical Services,
Dunedin).
legal parameters in the context of incidental findings given the absence
of legal certainty currently.
C Common law: the general duty to inform regarding the nature and
extent of a proposed procedure
In general a legal claim is theoretically possible in the (rare) case where consent to a procedure has not been obtained at all or, less rarely, when surgery has been performed “beyond that to which there was consent” in a non-emergency situation.25 Surgeons who have performed additional surgical procedures without specific patient consent, particularly when it involves removing reproductive capacity,26 have been held liable for battery27 or negligence and/or faced disciplinary proceedings.
It is also a central tenet of medical law that a patient should be provided with sufficient information prior to undergoing a procedure in order for the patient to make an informed choice.28 It is well established that the fact that the surgery performed is appropriate in the circumstances will not excuse a doctor for failing to inform a patient regarding the nature, and extent, of a proposed surgery,29 which is exemplified in the following case.
In O’Connell v Gelb30 a woman, who had previously
undergone gynaecological surgery and was suffering ongoing and unexplained pain,
consented to an examination
under anaesthetic to determine its cause.
25 Reibl v Hughes above n 5, at 890–891.
26 Hamilton v Birmingham RHA [1969] 2 BMJ 456 (no consent given to
sterilization during caesarean section – held battery); Devi v West Midlands
RHA (1981) (CA transcript 491) (no consent to hysterectomy performed
during operation to repair ruptured uterus following miscarriage – held
battery; Mohsina v Ornstein 2012 ONSC 6678 (surgery for pelvic problems,
surgeon clipped fallopian tube, held battery).
27 Mohr v Williams (1905) 104 NW 12 (Sup Ct Minn)(operated on left ear but
consent only obtained for surgery on other ear – held battery); Parmley
v Parmley and Yule [1945] 4 DLR 81 (patient underwent limited tooth
extraction, dentist removed all the patient’s teeth when he discovered
advanced tooth decay and gum disease – held battery), Boase v Paul [1931]
1 DLR 562, (patient attended dentist to have a single tooth extracted, all
were removed under anaesthetic, held negligence).
28 Rogers v Whitaker (1992) 174 CLR 479 (HCA).
29 Williamson v East London and City HA [1998] Lloyd’s Rep Med 6. The patient
underwent surgery for complications following breast augmentation
involving capsular contracture and leakage from silicone implants. An
operation to replace the implants and to perform an open capsulotomy
was proposed. Due to the extensive silicone granulosis of the breast and
muscle tissue discovered pre-operatively, the original surgical plan was
altered. A mastectomy was performed along with excision of part of the
chest muscle. Although the consent form was changed to reflect this,
the patient’s signature was not obtained. The patient claimed negligent
failure to inform regarding the nature and extent of the operation and
the performance of a non-consensual mastectomy. She was subsequently
awarded damages in negligence.
30 O’Connell v Gelb [1988] OJ No
1129.
The surgeon suspected a recto-vaginal fistula had developed following the initial surgery, but did not disclose this to the patient preoperatively. Nor did he disclose that if a recto-vaginal fistula was identified, surgical treatment could require formation of a temporary colostomy to allow the fistula to heal. After the patient was anaesthetised, a fistula was diagnosed. The surgeon, who had very limited experience in treating fistulas, requested assistance from a general surgeon who happened to be available at the time. The second surgeon attended, examined Mrs O’Connell while under anaesthetic and considered that a temporary colostomy was necessary, which he then performed.
The patient subsequently brought an action for damages on the basis that she
had not been informed of, nor consented to, the colostomy.
Despite the clinical
appropriateness of the actual procedure performed, the Supreme Court of Ontario
found the first surgeon liable
for damages. Clearly when, as in this example, a
condition/pathology is foreseeable and the patient could have been informed of
its potential preoperatively it is not an “incidental” finding.
Rather it is the result of a deliberate withholding of
relevant information.
However, what is of interest is O’Leary J’s observation in the
course of his judgment that:31
I have no doubt that Mrs O’Connell would have expected Dr Gelb to
repair any minor problem he should find during his examination
of her. She had
no idea, however, that she had the major problem (a fistula) that Dr Gelb was
aware of, or that any surgery, let
alone a colostomy, might be required.
O’Leary J’s statement implies that in consenting to an examination under anaesthetic, a patient might expect a surgeon to address any “minor” problem discovered in the course of that surgery. This suggests that it is the significance and/or magnitude of the intervention required to address the “problem” that has been discovered that is the material factor. It also suggests that the appropriate approach requires consideration of what a patient might reasonably consider falls within the scope of the consent given – which might include minor, but not major, interventions. However O’Leary J’s observation is inherently ambiguous. It leaves open whether this type of reasoning would be applicable to the case of incidental findings. It may simply mean that, if a surgeon does not know prior to commencing surgery what exactly might be found, intervention for “minor” findings that are associated with the presenting complaint will be acceptable as falling within the scope of consent provided.
An unexpected anomaly that is discovered intra-operatively that is seemingly
linked to the presenting complaint is not an “incidental”
finding as
defined in this paper. In this situation, the courts have been willing to find
that an intervention in respect of an
“unexpected” finding is not
unlawful if the intervention falls within the overall nature and
31 At [52]. The court awarded damages of $5000. A
greater amount was not provided because it was likely that, had she been
informed pre-operatively
that a colostomy might be required, she would have
consented.
purpose of the procedure for which consent was originally obtained.
In the Canadian case of Cowan v Brushett, the patient presented with a lump following a leg injury.32 The patient did not respond to treatment. After abnormalities in her thigh were detected on a scan, the clinician recommended that a muscle biopsy be performed. The consent form contained a broad consent clause. The patient consented not only to a muscle biopsy but also to “such further or alternative measures as may be found to be necessary during the course of the operation”.33
During the procedure the surgeon observed an area of bone that appeared abnormal. A bone biopsy was performed in addition to the muscle biopsy because of the risk of an underlying malignancy. After surgery, the woman fell and fractured her femur at the site of the biopsy. It was suggested implicitly that the biopsy had temporarily weakened her femur.
The patient claimed that she had not been informed post-operatively that a bone biopsy had been performed, nor was she warned of the need to avoid weight bearing on the affected leg. She brought a claim in battery and negligence alleging lack of consent to the bone biopsy and inadequate provision of post-operative advice.
The initial trial court found that the broadly worded consent form was too
vague to encompass the bone biopsy and found the surgeon
liable for battery.
However on appeal, the Newfoundland Supreme Court looked at all the relevant
circumstances in determining whether
consent covered the procedure. It held
that:34
... all relevant circumstances leading up to the surgery should be considered
when determining what the patient agreed to when he
or she submitted to the
procedure. Any written consent will bear obvious weight upon such an assessment.
However, inasmuch as many
formal consents are signed – as was the one in
the case at Bar – immediately before the surgery, on the threshold as
it
were of the operating room, when a patient is experiencing a certain degree of
trauma and stress, the circumstances leading up
to his or her presence at the
hospital are relevant to the patient’s intent and the consent form ought
to be read in light
of them.
The court found that the “overriding general purpose and intent” of the surgery was an ongoing investigative process to determine the cause of the problem with which she originally presented. Consequently it held that the biopsy was within the scope of the consent obtained.
Yet it was clear that Miss Brushett did not envisage the particular procedure being performed – which calls into question the legitimacy of the court inferring an intent to consent to that particular procedure. A more plausible explanation of the court’s judgment (although clearly not acknowledged) was that given the concern regarding malignancy, performing the bone biopsy constituted good clinical practice and public
32 Cowan v Brushett (1990) 69 DLR (4th) 743.
33 At [17].
34 At [15].
policy grounds existed for not finding a battery had occurred. This reasoning is supported by the fact that Miss Brushett’s claim of negligent post-operative advice was affirmed. Arguably, it was the lack of post- operative disclosure and after-care advice that was the critical factor in the case, rather than the procedure itself, which was recognized in the award of damages for negligence. In this situation it is suggested that it would have been preferable to find the surgeon justified on public policy grounds for performing a minor, additional diagnostic procedure, rather than infer patient consent.35
D Summary: Distilling the Common Law Position
In summary, the cases of incidental findings discussed in section B, all of which involved non-consensual removal of reproductive capacity, constituted extreme fact situations. It is hard to imagine a more devastating intervention than a surgeon’s unilateral decision to sterilize an individual. Removing reproductive capacity without consent, in a non-emergency situation, fails to respect the fundamental human rights of an individual. Importantly, the cases involved vague, if not dubious, clinical reasoning as to why the surgery was necessary in the circumstances. In this context it is unsurprising that the yardstick of lawfulness employed by the courts was that of emergency – permitting these particular procedures in anything but an emergency situation would clearly set too low a threshold for intervention.
But the question arises whether the same threshold of emergency
35 A similar critique may be applied to Pridham v Nash (1986) 33 DLR (4th)
304. Mrs Pridham consented to an exploratory laparoscopy to determine
the cause of her pelvic pain. The consent form included a clause
stating: “I consent to all preliminary and related procedures and to the
administration of general and other anaesthetics and to additional or
alternative procedures as may be necessary or medically advisable during
the course of such procedures.” An adhesive band was discovered which
the surgeon believed could cause episodes of subacute bowel obstruction.
The surgeon cut the adhesions. Mrs Pridham subsequently developed
peritonitis as a result of complications from the procedure. There was
no evidence of negligence on the facts. Pridham sued for damages on
the grounds that she only consented to an investigatory procedure. The
court found express consent to surgery stating: “If the laparoscopic
examination, an investigative procedure, had revealed a major problem
requiring surgery then, in my view, the surgeon would not be entitled
to rely on the original consent and the general words of the consent, as
quoted above, to carry out the major surgery ... However, this case, in
my view, is different. From a practical point of view it would have been
foolish for Dr Nash to wait for Mrs Pridham to come out of the anaesthetic
and then seek her consent to go through the same incision again to cut
the two adhesions. The additional curative surgery was of such a minor
nature that it falls practically in the same category as taking a sample for
biopsy” (at [20]). The authors suggest a better approach would have been
to find, on public policy grounds, that the surgeon acted reasonably in
the interests of preserving Mrs Pridham’s health and therefore was not
liable in battery.
should apply to all interventions, particularly in the case of incidental findings that, if addressed, would provide actual clinical benefits to the patient. While the House of Lords in Re F endorsed the doctrine of necessity as authorising medical treatment performed in cases of emergency, and in non-emergency situations where it is reasonably necessary in a (permanently) legally incompetent person’s best interests, it refrained from specifically considering the case of incidental findings.
The two other Canadian cases discussed in section C involved alleged lack of consent to additional procedures performed in the course of an operation. Although not involving “incidental” findings per se, some observations may be derived from them that are relevant to the issue.
In O’Connell v Gelb, it is arguable that the material factors for the court was the significance and implications of the intervention actually performed (colostomy) in conjunction with the deliberate withholding of diagnostic information and the potentially necessary surgical treatment. It is by no means an understatement to claim that living with a colostomy creates significant personal challenges and has extensive psychosocial implications for the patient. As such, it is unsurprising that the patient’s action was successful – even if only attracting a modest award of damages.36 Further, it is significant that the second surgeon who was called upon to perform the surgery once the operating surgeon realised the situation was beyond his expertise, was held not to be liable in the circumstances. The second surgeon’s rationale for operating was that the patient might develop septicaemia (blood poisoning) if a colostomy was not performed. The Court held that the second surgeon was “reasonably of the view that a colostomy was necessary to protect the health and life of Mrs O’Connell”.37 Yet on the facts, the fistula was not, it would seem, immediately life threatening. Indeed, one of the expert witnesses informed the court that leaving the fistula to heal spontaneously would have been a proper course of action.38
Consequently, it would seem that the rationale accepted by the Court was
concerned with preserving the patient’s health by preventing
potential complications arising from the fistula – as distinguished from
being a situation of “true”
emergency. Arguably the decision turns
more on the deliberate deception by the attending surgeon and his failure to
inform, than
restricting the scope of legitimate interventions to
situations
36 The judge said however that had she been informed “she would have been spared the shock of finding that a colostomy had been performed and without knowing why. She would have been spared some of the resentment she must have felt at having been deceived out of her right to decide what operation was to be performed on her and by whom”.
37 O’Connell v Gelb above n 26 at [56] citing Marshall v Curry above n 2.
38 However the judge observed that: “I am satisfied that a substantial
segment of reasonably competent gynaecologists and general surgeons
are of the opinion that a proper, if not the only, way to treat a rectovaginal
fistula of the kind suffered by Mrs O’Connell is by performing a colostomy
just as was done in this case”. At [49].
of true emergency.
In Brushett v Cowan the plaintiff was unsuccessful in claiming battery following a bone biopsy, ostensibly because of the broadly worded consent form. However, it is also plausible that the court did not find a battery had occurred because the rationale for performing the procedure was, prima facie, defensible on the grounds of good medical practice; i.e. to identify potential malignancy in a patient with an unexplained lump and abnormal bone presentation. Had the doctor not performed the biopsy and bone cancer was subsequently diagnosed his actions might, with hindsight, be considered inadequate. However, this more generous interpretation of the court’s decision does not suggest that the finding of negligent post-operative disclosure and advice was unjustified.
This alternative analysis of the Canadian jurisprudence sheds a different
light on these cases. It provides a more nuanced justification
of the Canadian
Courts’ decision making. Unlike Canada, New Zealand does not have a
similar cache of common law to examine,
possibly due to its unique medico-legal
framework. However, some decisions arising from the complaints and discipline
processes provide
some material for analysis.
II The New Zealand Medical Law Context
As indicated above, the ability for a plaintiff to sue a doctor in damages for personal injury (physical or mental injury resulting from the physical injury) arising from medical treatment39 has been removed as a result of the statutory accident compensation scheme in New Zealand. An exception to this arises if the circumstances warrant an award of exemplary damages, which requires not only outrageous, but subjectively reckless conduct.40
While it is theoretically possible for a patient who undergoes an unconsented surgical procedure, but who does not suffer personal injury, to bring a civil claim against a clinician, any compensatory damages awarded are likely to be extremely minimal in these circumstances and may not outweigh the cost of litigation. Additionally, a conscientious surgeon who acts in good faith and after appropriate consultation is most unlikely to be found liable for exemplary damages.
Despite this apparent lack of legal recourse, there are significant avenues
available for patients to challenge the appropriateness
of their medical
treatment in New Zealand. A complaint may be laid with the Health and
Disability Commissioner pursuant to the Health
and Disability Commissioner Act
1994 (HDC Act) on the basis that the patient’s rights (as established
under the Act) were breached.41 These rights include rights to: be
treated with respect; to dignity and independence; to receive
39 Accident Compensation Act 2001, s 32.
40 Accident Compensation Act 2001, s 317. See Couch v AG (No 2) [2010]
NZSC 27.
41 HDC Act 1994, s 31(2).
services of an appropriate standard and the right to make and informed choice and give informed consent.42
The HDC may also refer the complaint to the Medical Council if competence,
fitness to practice, or the appropriateness of the doctor
’s conduct is in
doubt.43 Following investigation by the relevant committee, charges
may, if appropriate, be laid before the Health Practitioner ’s
Disciplinary
Tribunal.
A The Health and Disability Commissioner Act 1994 and the Code of Consumers’ Rights
One of the objectives of the HDC Act was the promulgation of a Code of Health and Disability Consumers’ Rights. Regulations establishing the Code of Rights were introduced in 1996.44 It specifies 10 patient or “consumer ’” rights and corresponding duties on health service providers, which obviously encompasses surgeons.
Right 7(1) provides that services (which include health services and health care procedures) “may be provided to a consumer only if that consumer makes an informed choice and gives informed consent”. However, exceptions to this are provided “where any enactment, or the common law, or any other provision” of the Code provides “otherwise”. Consequently, unconsented intervention will not breach the law of torts if it falls within a common law exception as discussed above.
However for the purposes of Code liability, right 7 (4) provides that if “a consumer is not competent to make an informed choice and give informed consent, and no person entitled to consent on behalf of the consumer is available, the provider may provide services where –
(a) it is in the best interests of the consumer; and
(b) reasonable steps have been taken to ascertain the views of the
consumer; and (c) either, –
(i) if the consumer ’s views have been ascertained, and having
regard to those views, the provider believes, on reasonable
grounds, that the
provision of the services is consistent with the informed choice the consumer
would make if he or she were competent;
or
(ii) if the consumer ’s views have not been ascertained, the provider takes into account the views of other suitable persons who are interested in the welfare of the consumer and available to advise the provider.”
Given the unanticipated nature of incidental finings it is unlikely that,
even if a broad discussion regarding their potential occurrence
had
42 Code of Health and Disability Service Consumers’ Rights Regulations
1996, rights: 1; 3; 4; 7 respectively.
43 HDC Act, s 34.
44 Health and Disability Commissioner (Code of Health and Disability
Service Consumers’ Rights) Regulations 1996 (SR
1996/78).
occurred preoperatively, such a discussion will indicate with sufficient clarity the patient’s preferred course of action in the circumstances. In some intra-operative situations, it may not be possible to discuss a finding with a suitable person, such as a patient’s “significant other”. While it would always be wise to discuss such a situation with a surgical or other appropriate colleague, this will not always be possible due to time restraints or availability. Clause 3 of the Code is also relevant in this respect. It provides a general waiver that “a provider is not in breach of this Code if the provider has taken reasonable actions in the circumstances to give effect to the rights, and comply with the duties, in this Code”.45 In references to “circumstances” the Code specifies that this “means all the relevant circumstances, including the consumer’s clinical circumstances and the provider ’s resource constraints.”46 Importantly, the onus is specifically placed on the provider to prove that he/she “took reasonable actions”.47
An additional right that might be read in conjunction with clause 3 is found within right 4 that broadly encompasses the “right to receive services of an appropriate standard”.48 More specifically, right 4(4) confers a right to “have services provided in a manner that minimizes the potential harm to, and optimizes the quality of life” of the consumer.
The HDC opinions provide some indication of what the Commissioner considers to be non-justifiable medical intervention in the absence of consent. Although the HDC Act and the Code of Rights do not avail a complainant of the same remedies as is available under common law systems that retain a right to sue, the regulatory process is nevertheless concerned with promoting and protecting patient rights.49 In more serious cases a breach finding may also result in charges being laid in the Health Practitioners Disciplinary Tribunal by the Director of Proceedings.50
If a finding of Professional Misconduct is made, the Tribunal may impose significant penalties, including cancellation or suspension of a practitioners’ registration, censure, mandatory supervision or a fine.51
One highly pertinent HDC investigation that resulted in a breach
45 Clause 3(1).
46 Clause 3(3).
47 Clause 3(2).
48 Right 4(1) provides that “every consumer has the right to have services
provided with reasonable care and skill” and right 4(2) provides that
“every consumer has the right to have services that comply with legal,
professional, ethical and other relevant standards”.
49 The Commissioner may make recommendations (HDC Act, s 45).
Damages may only be obtained if, following investigation, civil
proceedings are commenced in the Human Rights Review Tribunal by
the HDC’s Director of Proceedings. Even then, damages are limited and
are not available for personal injury resulting from treatment (as defined
in the Accident Compensation Act 2001). See HDC Act, s 57(1).
50 HDC Act, s 49(1)(a)(i); Health Practitioners Competence Assurance Act
2003, s 100.
51 Health Practitioners Competence Assurance Act, s
101.
finding, as well as successful disciplinary action for Professional Misconduct, concerned a situation that is analogous to an intra-operative incidental finding.52 The case involved a patient who was morbidly obese who, after years of struggling unsuccessfully to lose weight, presented for gastric-bypass surgery. He had comorbidities related to his obesity and was on medication for hypertension and gout. His past medical history included several acute episodes of ill health related to his liver, the cause of which had not been definitively identified.
Prior to surgery the patient underwent routine blood tests, including liver function tests. However, the surgeon did not review the results until after the patient had been anaesthetized, despite them being available the day before. The blood tests indicated significant liver disease. Given the surgeon’s discovery at this point, the situation is arguably analogous to an incidental finding made during surgery.
The abnormal results meant that the risk of death as a result of surgery was “several times greater” than the risk previously advised to the patient.53
Despite this, the surgeon elected to continue with the operation. After discharge, the patient suffered a perforated duodenal ulcer, developed liver and kidney failure, and died. The liver pathology was subsequently determined to have been due to a rare genetic disorder, which caused cirrhosis of the liver.54
After investigation, the Health and Disability Commissioner found that the doctor breached the patient’s rights to receive information and make an informed consent under the Code of Rights. Charges were subsequently laid by the Director of Proceedings in the Health Practitioner ’s Disciplinary Tribunal (Tribunal).55 The Tribunal upheld a charge of Professional Misconduct for proceeding with risky elective surgery in a non-emergency situation and denying the patient a choice whether to undergo surgery in those circumstances.56
The significant point is that, as a result of the newly discovered
information, the known risks associated with the surgery were significantly
increased. This information constituted a material risk- factor for the
patient. Arguably, the case is primarily about the duty
to inform of relevant
risks prior to surgery and an associated duty not to proceed with an elective
procedure when significant additional risk factors are discovered. While
it is true that there was no “emergency” that might have justified
the intervention,
it was also clear that the Tribunal rejected the
surgeon’s argument that proceeding was in the best interests of the
patient,
particularly given the patient’s cautious
52 Decision 271/Med09/113D Health Practitioners Disciplinary Tribunal
53 At 7.
54 This was diagnosed as alpha 1-antitrypsin deficiency.
55 Decision HDC07HDC11318 Health and Disability Commission
56 Decision No 271/Med09/113D Health Practitioners Disciplinary Tribunal
approach to the surgery in the first place.57 The surgeon’s conduct was unacceptable because, given the circumstances and absence of consent, it was simply not justifiable. This suggests a rule of thumb against surgical intervention for an incidental finding, or continuing with a planned surgery, if addressing the incidental finding or its very existence increases the overall risks associated with the original surgery.
Another procedure that was held to breach the right to be informed and give informed consent concerned a case of a 29-year-old woman who presented with abdominal pain. The specialist suspected endometriosis (abnormal growth of uterine tissue outside the uterus). The patient signed a consent form authorising an investigatory laparoscopy, surgical treatment of any endometriosis found (resection and ablation), and a tubal patency test. During the surgery, polycystic ovary syndrome (PCOS) was discovered. Ovarian drilling (diathermy) was performed. The patient had a complicated recovery and initially experienced ongoing pain.
Sixteen months later, the patient attended a different surgeon for a second opinion after experiencing recurrent pain. The second-opinion doctor discussed the patient’s prior surgical treatment – including the PCOS diagnosis and the ovarian drilling. The patient claimed, and the Commissioner accepted, that PCOS had not been discussed with her as a potential diagnosis preoperatively. It followed that ovarian drilling had not been discussed either and the patient had not consented to such a procedure. (Although the doctor disputed this lack of disclosure, the evidence indicated the patient’s version was more credible.58) The surgeon claimed that ovarian drilling constituted good practice in the treatment of PCOS.
The Commissioner ’s expert advisor explained that ovarian drilling is
usually performed to stimulate ovulation in individuals
who are experiencing
infertility due to a failure to ovulate regularly, which was not an issue in
this particular patient’s
case. The associated risks of ovarian drilling
included loss of ovarian tissue, reduced ovarian reserve and adhesions. The
expert
advisor noted that the patient had undergone ovarian surgery in her
teens; consequently preservation of ovarian reserve was a particularly
important
issue for her. The advisor also noted that he was not aware of any clinical
evidence to support the surgeon’s rationale
for performing the drilling,
which was to reduce the “weightiness” of the ovaries. The advisor
continued:59
[i]t is reasonably common that an unexpected finding is made at laparoscopy
and the surgeon is expected to act in the patient‘s
best interest.
Regardless of the surgeon’s actions, if an unplanned or
unconsented
57 At 76.
58 The HDC opinion details evidential anomalies that called the veracity of
the surgeon’s claims into question. See HDC07HDC 11318 above n 55 at
12.
59 Decision 08HDC08813 at 25 Health and Disability Commission
procedure is undertaken, I would expect that a detailed description of the
findings, a justification for the procedure and a detailed
description of the
procedure would be clearly documented.
The surgeon did not undertake any of these actions. The Commissioner found
that the patient’s right to give an informed consent
(right 7(1)) had been
breached. It was stated that:60
[n]otwithstanding Dr B’s assessment of Ms A’s best interests,
there was no legal justification for her to drill Ms A’s ovaries
without her informed consent. This was not an emergency situation. The decision
whether to proceed
with this treatment option was Ms A’s alone to
make.
However, it is arguable that framing the decision this way missed the main issue – which was not whether the procedure was performed in the context of an emergency, but whether the procedure was consistent with good medical practice. The expert advisor was not aware of any evidence that would support the surgeon’s rationale for performing the procedure.61 Further, the surgeon failed to directly inform the patient subsequently of the PCOS diagnosis, the actual procedure performed, the rationale underlying it, and any necessary implications.62 Such a failure suggests conduct that falls short of the standard of care expected of surgeons. It seems that premising the breach, even tangentially, on a lack of emergency does not accurately reflect the nature of the wrongdoing, which was broadly poor clinical practice. However right
4, which encompasses the right to “services of an appropriate standard”, was only invoked in the context of poor documentation in clinical notes. The Commissioner made several recommendations as a result of his finding that the surgeon breached the patient’s right to informed choice and consent.63 Of interest, however, are comments made by the Commissioner ’s expert advisor.
The expert advisor considered that a surgeon will generally act reasonably
and justifiably in addressing an unexpected or unanticipated
condition if they
consider it to be in the patient’s best interests—which presumably
encompasses incidental findings.64 In determining the
60 At 16.
61 At 26.
62 However, the procedure was documented in the discharge summary
provided to the patient.
63 The Commissioner recommended that Dr B apologise to Ms A and
that Dr B review her practice in light of the expert advisor ’s report/
comments. A copy of the HDC report was sent to the Medical Council of
New Zealand and the private hospital. As well, an anonymised copy was
sent to the Royal Australian and New Zealand College of Obstetricians
and Gynaecologists, and the District Health Board. (These bodies were
advised of Dr B’s name). An anonymised copy of the report was also sent
to the Royal Australasian College of Surgeons, the New Zealand Private
Surgical Hospitals Association, Women’s Health Action Trust, and the
Federation of Women‘s Health Councils Aotearoa/New Zealand, and
placed on the HDC website.
64 At 27.
appropriateness of the procedure the advisor applied a subjective test of whether, in the context of the particular patient, it was reasonable to perform the procedure. Further, he considered that, at a minimum, the findings, the procedure performed, and the justification for performing the procedure at that time should be fully documented and the patient informed in the post-operative period.
In contrast, it was apparent in the HDC opinion that right 7(1) required express consent except in exceptional circumstances “such as provision of life-saving treatment in an emergency, or when a consumer does not have the mental capacity to consent on her own behalf”.65 This tension was not explored in the HDC opinion itself.
This apparent theory-practice dissonance suggests that, at least for some surgeons, it is not simply a matter of only acting if the situation involves a clinical emergency. Rather, it is a case of ensuring that any intervention performed in the context of an unexpected or incidental finding is accompanied by good clinical reasoning, post-operative disclosure and appropriate post-operative care.
An older example concerns a decision of the Medical Practitioners Disciplinary Committee (since superseded twice) that was discussed in the New Zealand Medical Journal.66 The unnamed specialist was found guilty of Professional Misconduct in three separate incidents, two of which involved performing procedures without consent.
In one of the incidents, the surgeon carried out a tubal ligation
(sterilisation) on a woman in the course of performing a caesarean
section. The
specialist claimed that he had conditional consent if he found it necessary
to do so. The Committee was not persuaded that there had been consent for
tubal ligation, nor was there any expectation on the part
of the patient, or her
husband, that it might be performed. While it was acknowledged that there may
have been some misunderstanding
it said:67
in matters of this gravity there was no room for misunderstanding by the
surgeon. While the specialist may have thought he was doing
what he believed
was in the best interests of the patient, he was not justified in sterilizing
the patient at a time when there was
no emergency.
As discussed above, performing a sterilization procedure on a patient in the
absence of express consent is a significant departure
from standards of good
medical practice. Given the implications of the procedure it constitutes a
considerable breach of the patient’s
rights. In the case of
65 At 11, fn 17.
66 See “Failure to Obtain Consent, and Refusal of Public Hospital Treatment”
(1992) 105 New Zealand Medical Journal 461. The Medical Practitioners
Disciplinary Committee (created by the Medical Practitioners Act 1968)
preceded the Medical Practitioners Disciplinary Tribunal (constituted
by the Medical Practitioners Act 1995) which has since been replaced by
the Health Practitioners Disciplinary Tribunal (pursuant to the Health
Practitioners Competence and Assurance Act 2003).
67 At 461.
the ovarian drilling the wider circumstances raised concerns, including the questionable rationale for performing the procedure, the lack of direct disclosure to the patient regarding its performance and reason for performing it, or any explanation of the implications that PCOS had on the future health of the patient.
In these cases it was not primarily the lack of emergency that was at issue
– but arguably broader issues of poor clinical practice.
What is apparent
is that in these situations a lack of “emergency” is in danger of
becoming a proxy for denouncing conduct
that, in general, falls short of
expected professional standards. This has seemingly resulted in a widespread
misperception that
it is only in situations of emergency that
non-consensual intervention will be lawful – yet this is not necessarily
the case if a nuanced and careful approach is
taken.
III Incidental Findings: the Price to be Paid for Autonomy or an
Appropriate Legal Response?
It is apparent that incidental findings are, and will always be, part of surgical practice. If these arise in the context of an emergency it is well established that action is justified in the interest of preserving life or health.
A review of the case law suggests that responding to an incidental finding in the course of surgery is implicitly restricted to emergency situations. Necessity has been judicially interpreted as strictly limiting the scope of non-consensual intervention in general, rather than simply providing a discrete justification for non-consensual intervention in emergency situations. However, it is debatable whether such an application of the doctrine is desirable in respect of many unanticipated incidental findings.
It is possible that there is a category of case that, while not consisting of an imminent risk to life or health, a surgeon might nevertheless be justified in addressing in the interests of that individual. As was pointed out by Lord Goff in Re F, the legal propriety of treatment in the absence of consent should be premised on the “necessity” of the treatment, rather than the “emergency” context.
This suggests that it may be justifiable to intervene even if it is not an
emergency, subject to minimum legal and clinical requirements.
Further, acting
in the interests of preserving health (which constitutes one limb of the
necessity justification after all) provides
a far more expansive scope of
justification than has previously been recognised in the jurisprudence. In this
respect one medical
law expert has cogently observed:68
[c]learly, a general anaesthetic is not to be taken as providing a warrant
for whatever additional interventions could be regarded
as being to the
patient’s benefit. But it would be undesirable for patients to be
exposed
68 PDG Skegg “Justifications for Treatment
Without Consent” in PDG Skegg and Ron Paterson (eds) Medical Law in New
Zealand (Thomson Brookers, Wellington 2006) at 244.
to the inconvenience, risk, and sometimes cost, of a second operation, and
for further operating time and staff resources to be expended,
whenever an
unforeseen condition is discovered. A test of whether it would be
unreasonable to delay, rather than to proceed immediately, might be
appropriate.69
Preserving health need not be restricted to life-threatening conditions or disorders, but would include a spectrum of factors that impact on a patient’s health and well being to a greater or lesser extent. If this claim is accepted, it is obvious that some normative principles would be necessary to inform a legal test and guide clinical decision making. This is discussed further below.
A An Alternative Approach?
There are several legal and policy options that might be considered to provide guidance regarding incidental findings that pose a risk to the health of the patient. The first is to maintain the apparent status quo – which is to narrowly restrict the circumstances in which a surgeon may attend to an incidental finding. This approach is premised not only on the autonomy of the patient but also on a pragmatic need to deter “outlier” surgeons. However as already suggested, it is not necessarily desirable that such a strict rule be adopted, nor does it ensure good medical practice in general.
Another possible approach is to adopt the notion that a patient, in consenting to surgery, thereby entrusts the surgeon to act on their behalf. On this account, the surgeon effectively constitutes the patient’s “representative” endowed with the authority to make decisions based on the surgeon’s conception of the best clinical interests of the patient. However, a salient point made in Marshall v Curry is that in situations like these it is best to avoid adopting a legal fiction as a solution.70 That is, it is a better legal approach to determine when a surgeon will have a justification for acting without express consent, rather than inferring an authority to act. Obviously in these situations the onus of proof would lie with the surgeon.
An alternative approach would be to employ the test of “presumed consent”. On this approach an intervention would be justified if it can be presumed that, had the patient been given the opportunity when competent to make a decision, they would have given consent in the circumstances. Again this is problematic because it is based upon a legal fiction. It is a “best-guess” type of approach in a context where it is preferable to craft a justification, rather than to import a presumption. On the other hand, it would be extremely unwise to proceed if a surgeon is aware that doing so is likely to be contrary to the patient’s wishes.
The patients’ “best interests” are most likely to be invoked when
surgeons justify acting without specific consent in this context.
However,
69 Citing PDG Skegg Law, Ethics and Medicine: Studies in Medical Law
(Clarendon Press, 1984) at 104.
70 Above n 2, at 454. See also Re F above n 2, at 37 per Butler
Sloss LJ.
although the best interests of the patient will obviously represent the clinical reasoning underlying a decision to proceed with an unconsented procedure, it is nevertheless problematic from a legal and patient- centered perspective. “Best interests” simpliciter is problematic because the only person who categorically knows what is in their “best interests” is the person at the heart of the decision themselves – who obviously is unable to indicate at that precise time, what constitutes their best interests.
An alternative approach is to raise the possibility of incidental findings with a patient in a preoperative discussion. It is possible that patient consent forms might be amended to expressly provide for the possibility of an incidental finding. However for some patients, discussing the possibility of incidental findings may add further complexity to decision- making and cause additional anxiety. Obviously an incidental finding, by its very nature, cannot be anticipated so discussing the matter in advance would pose its own challenges. Also in some circumstances of urgency, it will be unreasonable to extend or complicate the consent process.
Nevertheless, including a clause referring to incidental findings on consent forms may be desirable. However two issues are relevant. First, there is a danger that some surgeons may be over reliant on such clauses and fail to engage the patient in a meaningful discussion regarding the potential for incidental findings. Another related consideration is the risk that a surgeon may overestimate the legal protection offered by such statements. In the event, an adjudicator may simply discount a clause as being too vague to provide legal authorisation if a procedure does not fall within the nature and purpose of the original consented surgery or if there has been insufficient discussion between patient and surgeon. That said, such a clause could encourage a useful discussion to ascertain the patient’s views regarding any potential incidental finding in some circumstances.
Clearly some patients might expect that a surgeon will not carry out a non-consented procedure in any circumstances. Even if a surgeon intervenes based on what he/she considers is the patient’s best interests, this will not necessarily justify non-consensual intervention if a patient subsequently challenges the lawfulness of the intervention. Ultimately, for surgeons faced with this clinical scenario the most desirable approach is to establish, as far as is possible, some consensus regarding the acceptable boundaries of intervention. It is likely that additional factors, such as those discussed below, would be highly relevant in these circumstances.
B Proposing a Legal Test / Justification
When an incidental finding is discovered that poses a risk to the health of
the patient, even if it is not an immediate risk, and there is no-one
available to provide proxy consent, the authors propose adopting a pragmatic
legal approach. This approach,
which is based on the principles derived from the
case law and HDC opinions discussed above, broadly opines that:
A surgeon who discovers an intra-operative incidental finding and who, after
taking into account all of the relevant circumstances
(clinical and otherwise)
reasonably considers that performing an additional intervention is necessary in
the interest of preserving
that patient’s health, and who has no reason to
believe that the particular patient would object in the circumstances, and
who
performs the additional procedure with reasonable care and skill, shall be
presumed not to incur civil or disciplinary liability
for proceeding without
consent.
Obviously this test leaves open what constitutes reasonably considered by a surgeon to be in the patient’s interests in the circumstances and imports an objective element into the test. The obvious starting point as to what might influence the reasonableness of a surgical decision is that convenience alone will never constitute sufficient reason to proceed.71 So, for example, the finding must involve some pathology, and removing a healthy appendix without consent simply as a matter of convenience would not be justifiable. Another relevant factor is the reasonableness of the procedure performed. This inquiry will entail a consideration of what constitutes good clinical practice in regard to the anomaly discovered and any relevant characteristics of the patient such as age, additional health conditions or comorbidities. It will also turn, in part, on the gravity and implications of the procedure that is performed and whether there are less extensive (or destructive) options available.
Such a clinical scenario might arise, for example, in the case of a large abnormal ovarian growth discovered in the course of bowel surgery. Simply ignoring the growth is unlikely to be considered the preferable outcome for most patients. However removing an ovary has repercussions on fertility and hormone function, which may be highly relevant to that particular patient. Performing a biopsy to determine if the growth is malignant will be less destructive of ovarian tissue than a full oophorectomy (removal of the ovary). This is significant if the mass is not, in the event, malignant. Adopting the least invasive/destructive option could be considered by the individual to be less intrusive of their autonomy. This “proportionate” approach might also be considered consistent with Lord Goff’s observation that a doctor “should do no more than is reasonably required, in the best interests of the patient, before he recovers consciousness”.72 On the other hand, a biopsy may be contraindicated because of the risk that, if the mass is indeed cancer, the biopsy itself may spread malignant cells and compromise the patient’s outcome. Clearly such situations call for careful clinical judgment.
It is apparent that much of the case law involving actions in battery has
involved surgery that resulted in a loss of reproductive
capacity. This provides
a clear indication for extreme caution when a procedure would adversely affect
fertility or hormone function.73 The same applies
71 Marshall v Curry, Murray v McMurchy, Re F above n 2.
72 Re F above n 2, at 77.
73 See Husain v Daly [2012] ONSC 919. Consent given for myomectomy to
remove uterine fibroids. Upon finding a different condition, the
surgeon
to other procedures that impact on an individual’s lifestyle, such as the removal of both ovaries when the patient has expressly articulated concern regarding the implications of such surgery,74 or formation of a colostomy.
The nature of the procedure may also impact on the reasonableness of considering a particular procedure to be in a patient’s best interests. If it adversely affects recovery and prolongs recovery time, negatively affects the patient’s aesthetics, or will cause significant additional pain it would be more difficult to reasonably consider intervention to be in a patients interest.75
The reference to all circumstances means not only clinical circumstances, but extends to social and emotional circumstances. In the case of extensive surgery, the patient may need to be adequately prepared and make special arrangements for themselves and/or others that would necessitate specific and express consent. If immediately treating the finding significantly increases the risks associated with the primary procedure it is less likely to be reasonably in the patient’s interests to proceed at that time.76 Whether the surgeon has the relevant expertise is also an important consideration.
Requiring that the decision be made in regard to this particular patient
imports a patient-centred element to the test. A final minimal requirement
of good practice is that the patient is informed of the
nature of the finding
and the reason for the clinical intervention at the earliest
opportunity
performed a hysterectomy. The 46-year-old patient had not given up her “dream” to become pregnant. The surgeon was held guilty of wrongful hysterectomy. General damages of $75,000 awarded.
74 See Astaphan v Scarborough General Hospital [1996] OJ N0 2666 (Gen Div).
Consent was obtained for a laparoscopy and, if necessary, removal of
the patient’s right ovary. Prior to surgery the patient expressed concern
regarding hormone replacement therapy because her mother had suffered
breast cancer. She was assured that one ovary would produce sufficient
estrogen to avoid this. During surgery both ovaries were removed after
the left ovary was found to be diseased. The evidence suggested that the
patient might have needed the surgery on the left ovary within a year. The
patient brought an action in damages. Although the patient had signed
a consent form including consent to “such additional operations as are
considered therapeutically necessary on the basis of the findings during
the course of the operation”, the Court held that in the circumstances the
clause was insufficient to cover the removal of the left ovary in a non-
emergency situation. The doctor was held liable in damages for battery.
75 For example in an Australian case, changing the procedural approach
to that which the patient had consented was held to constitute a failure
to obtain consent in broad terms. The plaintiff was admitted to hospital
for laparoscopic tubal ligation. She alleged that she was subjected to a
laparotomy (a significantly more invasive procedure) without her consent,
leaving her with an abdominal scar, continual abdominal cramps and
pain. The plaintiff succeeded in her claim and was awarded damages.
See Candutti v ACT Health and Community Care [2003] ACTSC 95.
76 Decision 271/Med09/113D, above n 56.
post-operatively.
Clearly a clinical decision will depend on multiple factors in this context.
However it is certainly arguable that a surgeon who provides
a clinically robust
and reasoned justification for addressing an incidental finding in accordance
with criteria such as those discussed
should not be liable for acting
appropriately to preserve the health of a patient in this context.
Conclusion
At present there is a lack of information regarding the incidence, nature, and various clinical responses to incidental findings and a similar lack of legal certainty on the issue. Addressing an incidental finding is a complex issue because it is not foreseeable with any certainty what a patient would wish. While this article has made an attempt to address some of the issues and formulates a tentative test of lawfulness, the subject is highly amenable to empirical study involving both surgeons and patients. Such empirical research could usefully inform this apparent theory-practice gap in the interests of making relevant law and policy more connected to its subject matter and therefore more meaningful and legitimate for patients and surgeons alike.
It is apparent that discovering an incidental finding during surgery is a not infrequent issue that most surgeons confront in the course of their careers. However, discovering an incidental finding once a patient is anesthetized presents significant medico-legal challenges. The situation is often time-pressured and is always context specific.
The dearth of cases and complaints on the issue suggests either that, for the most part, surgeons who treat incidental findings get it right on behalf of their patients, or alternatively, that surgeons generally refrain from performing beneficial interventions in this context. As is typical with medical law, the few cases that exist tend to be those most extreme cases. Arguably as a result, the threshold of a lack of “emergency” has been used as a determinant in cases involving egregious breaches of patient autonomy.
However, this article cautions against uncritically using a lack of
“emergency” as a proxy for denouncing clinical practice
that falls
below the bar. It also suggests that by deriving applicable legal principles
from relevant cases, and engaging more closely
with the pertinent issues, legal
policy might become more robust and better informed. It suggests a test that
might provide some
clarity in a context that, at least for many doctors, lawyers
and adjudicators, is extremely grey. The legal threshold test proposed
is that a
surgeon who discovers an incidental finding and who:
after taking into account all of the relevant circumstances (clinical and
otherwise) reasonably considers that performing an additional
intervention is
necessary in the interest of preserving that patient’s health, and who has
no reason to believe that the particular
patient would object in the
circumstances and who performs the additional procedure
with reasonable care and skill, shall be presumed not to incur civil or
disciplinary liability for proceeding without consent.
This test represents an attempt to import some flexibility into the law, while keeping the patient at the locus of the decision. It presupposes that the surgeon has no reason to believe that the patient would not want to undergo the procedure at that time.77 It is also premised on imposing a duty on the clinician who responds to an incidental finding to consult with an appropriate colleague (if possible in the circumstances) and to provide a robust rationale for performing the additional surgical intervention in the circumstances. It also requires thorough documentation, patient disclosure and appropriate communication with the patient post-operatively.
It is unquestionable that autonomy is a vital and hard-won right. Any public
policy that potentially undermines this principle is
to be treated with caution.
The argument presented in this paper certainly does not seek to weaken patient
autonomy, but rather to
provide a pragmatic, realistic solution to a difficult
and not infrequent issue by identifying a legal threshold for intervention
and
appropriate safeguards. Of course, the alternative is to accept that any
additional intervention in this context will always contravene the law, and
any inconvenience or delay in diagnosis or treatment experienced
as a result is
simply the price to be paid for autonomy. However for many of us, the resulting
opportunity- cost is disproportionate
as we potentially risk losing something of
greater value – our
health.
77 See Astaphan v Scarborough General Hospital, above n 73.
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